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Color Additive Status List

This status list, formerly called Appendix A of the Investigations Operations Manual (IOM), provides current information concerning color additives, and will enable you to determine the status and limitations of most color additives likely to be encountered in a food, drug, device, or cosmetic establishment.

To maintain concise form, this list is limited in many respects involving certification, regulations, labeling, etc. For specific details concerning these matters, please refer to the source documents, Code of Federal Regulations (CFR, Title 21, Parts 70 to 82) and to the Federal Food, Drug, and Cosmetic Act, as amended, Sections 601(e), 602(e), 706, [21 U.S.C. 361(e), 362(e), 376] and as it pertains to Sections 201(s)(3) and (t), 402(c), 403(m), 501(a), and 502(m) [21 U.S.C 321(s)(3), and (t), 342(c), 343(m), 351(a), and 352(m)].

Any color additives not included in this listing and found in the possession of manufacturers or processors where they may be used in foods, drugs, devices, or cosmetics should be referred to your district for consideration. Your Servicing Laboratory for color analysis is also a good reference source.

LAKES: Color additive lakes are provisionally listed under 21 CFR 81.1. Part 82 of 21 CFR explains how lakes may be manufactured and named and lists the color additives that may be used to manufacture lakes. All lakes are subject to certification.

Examples of nomenclature of lakes:

The name of a lake is formed from the name of the color additive combined with the name of the basic radical and the word "Lake". For example, the name of the lake prepared by extending the aluminum salt of FD&C Blue No. 1 upon alumina would be FD&C Blue No. 1 - Aluminum Lake.

If a lake is prepared by extending an FD&C color additive on a substratum other than alumina, the symbol "FD&C" will be replaced by "D&C". For example, the name of the lake prepared by extending the aluminum salt of FD&C Blue No. 1 upon a substratum other than alumina would be D&C Blue No. 1- Aluminum Lake.

NOTE: You are cautioned that this Exhibit is condensed and should be used for screening and guidance only. When you encounter situations involving possible violations of color additive regulations check the latest basic document as indicated in the second paragraph of this preface. Be certain of the complete status and report the facts. It is the district responsibility to instigate appropriate action, not yours. Do not advise firms to destroy stocks of possible suspect merchandise or institute recalls without district clearance.

Color additives subject to certification and permanently listed (unless otherwise indicated) for use in FOOD. Most are also listed for use in DRUGS AND COSMETICS as noted. (None of these colors may be used in products that are for use in the area of the eye, unless otherwise indicated).

FD&C Red #40 and its Aluminum Lake - Food, drugs and cosmetics, including drugs and cosmetics for eye area - GMP. Other lakes for food, drugs and cosmetics are also permanently listed - 74.340, 74.1340, 74.2340

Color additives subject to certification and permanently listed (unless otherwise indicated) for DRUG AND COSMETIC use. (None of these colors may be used in products that are for use in the area of the eye unless otherwise indicated)

D&C Red #36 - Drugs: ingested drugs, other than mouthwashes and dentifrices, if taken continuously for < 1 year (at most 1.7 mg per day); ingested drugs if taken continuously for > 1 year (at most 1.0 mg per day); and external drugs (GMP). Cosmetics: lipsticks (at most 3% by wt. of finished product), and external cosmetics (GMP) 74.1336, 74.2336, 82.1336

Color Additives subject to certification and permanently listed (unless otherwise indicated) for use in EXTERNALLY APPLIED DRUGS & COSMETICS. (None of these colors may be used in products that are for use in the area of the eye)

Color additives exempt from certification and permanently listed for DRUG use. (None of these color additives may be used in products that are for use in the area of the eye, unless otherwise indicated.).

Alumina - Drugs generally - GMP - 73.1010

Aluminum powder - Externally applied drugs, including those for eye area use - GMP - 73.1645

Annatto extract - Drugs generally, including those for eye area use - GMP - 73.1030

Beta-carotene, natural and synthetic - Drugs generally, including those for eye area - GMP - 73.1095

Vinyl alcohol/methyl methacrylate - dye reaction products - contact lenses - GMP - 73.3127. The color additives are formed by reacting one or more of the following dyes with vinyl alcohol/methyl methacrylate copolymers: